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{"title":"ISO13485 Rapid Neutralizing Antibody Test Kit 95.00% Acuracy","imgUrl":"https:\/\/img.silkroadsl.com\/nimg\/d2\/e3\/2a3618a07795b199c1ccc1ce808e-200x200-1\/iso13485_rapid_neutralizing_antibody_test_kit_95_00_25_acuracy.jpg","attrs":{"Brand Name":"LABNOVATION","Model Number":"LX-401701","Certification":"ISO13485, ISO9001, CE","Place of Origin":"China"}}
Rapid Test Kit CoV-19 Nqeutralizing Antibody Rapid Test Kit Easy For Use 20 Test / Kit
Intended Use
The kit is intended for the semi-quantitative determination of neutraliaing antibodies to SARS-Cov-2 in human serum, plasma, fingerstick wholeblood or venous whole bood specimens. Results are for the detection of total neutralizing antibodies to SARS-COV-2. Antibodies to SARS-COV-2 are generally detectable in blood several days after initial infection, although the duration of time neutralizing antibodies are present post-infection is not well characterized.
The test is intended use as an aid in identifying individuals with an adaptive immune response to SARS-COV-2, indicating recent or prior infection or assisting in evaluating the effectiveness of the vaccine clinical trials and mass vaccination.
Specifications
Test Item
Neutralizing Antibody Test Kit
Sample Volume
Whole blood 20µL, Serum/Plasma 10µL
Package
20 Test/Box
Specificity
98.00%
Sensitivity
97.67%
nspection Method
Immunochromatography
Shelf Life
18 Months
Type
IVD Antibody Rapid Test
Main Components
Test cassettes
Disposable pipettes
Sterile Safety Lancets
Sample Buffer
Colorimetric chart
Instruction for use
Product Feature
Fast results as soon as 10-15 minutes
Facilitates patient treatment decisions quickly
Simple, time-saving procedure
Little specimens, easy for use
All necessary reagents provided & no equipment needed
High sensitivity and specificity
Advantage
Accurate: the product has a high accurate serology test for Neutralizing Antibodies detection
Easy to administer and read results: no need for instrument or other equipment during the test
Fast detection: the result appears in 10 minutes, can be used for testing on a massive scale.
No specific storage requirement: room temperature (2-30ºC)
Use Step
Place the lanceton the test site.
Push down the lancet.
Collect the bloodby transfer pipette.
Add one drop of blood into the sample well.
Add 1-2 drops (30-60µL) of sample buffer into the sample well innediately.
Wait 15 minutes then read the result.
Interpretation of results
POSITIVE: The T line and C line are both displayed within the reaction window, indicates the neutralizing antibodies to SARS-COV-2 are detected. The result is positive.
NEGATIVE:The C line is displayed within the reaction window only, indicates absence of neutralizing antibody to SARS-COV-2.The result is negative..
INVALID:1. If the control (C) line is not displayed in 15 min, regardless of whether T line is present, the test result is invalid. It is recommended that the specimen should be re-tested. The test result is invalid after 20 min.
Other Information
The test is for in vitro diagnostic use only.
This test is designed for semi-quantitative detection of SARS-COV-2 neutralizing antibodies.
It is unknown at this time if the presence of antibodies to SARS-COV-2 confers immunity to re-infection. Consider other information including clinical history and local disease prevalence, in assessing the need for a second but different serology test to confirm an immune response.
Applicaton
Evaluation of Vaccination
Diagnosis of Infection
Assessment of Convalescent Plasama Therapy
Epidemiology Research
Company Details
Bronze Gleitlager
,
Bronze Sleeve Bushings
and
Graphite Plugged Bushings
from Quality China Factory
Business Type:
Manufacturer
Year Established:
2001
Total Annual:
10000000-50000000
Employee Number:
100~600
Ecer Certification：
Active Member
Labnovation Technologies, Inc. is an original manufacturer established in Shenzhen, China since 2001. We are dedicated in developing and manufacturing IVD instruments and reagents including HbA1c analyzer and reagents, rapid test reader & reagents, hematology reagents, clinical chemistry reagent... Labnovation Technologies, Inc. is an original manufacturer established in Shenzhen, China since 2001. We are dedicated in developing and manufacturing IVD instruments and reagents including HbA1c analyzer and reagents, rapid test reader & reagents, hematology reagents, clinical chemistry reagent...
